Data / Medical devices / United States / Whip-Mix Corp.
Whip-Mix Corp.: FDA-registered device maker in Louisville, KY, United States, 2 510(k) clearances
Whip-Mix Corp. is registered with the FDA (registration 1043617) in Louisville, KY, United States. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1043617
- Address
- 361 Farmington Ave. P.O. Box 17183, Louisville, KY, United States, 40209
- Owner or operator
- WHIP MIX CORPORATION (1043617)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 28, 1977
- Registered through
- 2026
- Brand names listed
- ARDENT DENTAL ARTICULATING PAPER, ARDENT DISPOSABLE DENT, Cross Ref, Denar, Denar Best Bite Registration, Denar Bite Reg wax, FILM, Facebow for dentistry and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Specification developer | accessdata.fda.gov |
| Articulators | EJP | 1 | Manufacturer | accessdata.fda.gov |
| Facebow | KCR | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Articulation Paper | EFK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 18, 2025 | K241729 | Hard Splint & Thermo-Adaptive Splint | MQC | Substantially Equivalent | Whip Mix Corporation | accessdata.fda.gov |
| July 10, 2019 | K190107 | VeriSplint | MQC | Substantially Equivalent | Whip Mix Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Impression, Preformed
- All makers of Paper, Articulation
- All makers of Material, Impression Tray, Resin
- All makers of Mouthguard, Prescription
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Articulators
Updated March 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.